Structural and Functional Brain Reorganization in Neuropathic Pain. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic (ALLO)

Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).

This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity and reorganization of brain activity.

Previous studies in functional neuroimaging have focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally.

The objective of this study is to understand the brain dysfunction that induces allodynic pain considering the deafferentation of each patient and possible cortical losses.

Study Overview

• Status: Terminated
• Conditions: Neuropathic Pain
• Intervention / Treatment: Other: stimulation on painful area (area allodynic); Other: same stimulation on non-painful area; Radiation: MRI scan

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• with neuropathic pain
• in the case of central lesions, the lesion must be unique and small
• treatment not stable opioid for one week
• consent signed

Exclusion Criteria:

• severe psychiatric history
• presence of an evolutive lesion, expansive, cancerous or tumorous underlying
• patient needing of opioid therapy
• contraindication at MRI scan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients with pain allodynic peripheral	Other: stimulation on painful area (area allodynic); these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable. stimulations for 6 seconds; Other: same stimulation on non-painful area; these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable. stimulations for 6 seconds; Radiation: MRI scan; 2 sessions for 10 minutes : 11 controls stimulations for 6 s each spaced 20 s without stimulation.; 11 allodynic stimulations for 6 s each spaced 20 s without stimulation.
Other: patients with pain allodynic central	Other: stimulation on painful area (area allodynic); these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable. stimulations for 6 seconds; Other: same stimulation on non-painful area; these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable. stimulations for 6 seconds; Radiation: MRI scan; 2 sessions for 10 minutes : 11 controls stimulations for 6 s each spaced 20 s without stimulation.; 11 allodynic stimulations for 6 s each spaced 20 s without stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the deafferentation rate	the deafferentation rate measured with thermo-test	at baseline
gray matter rate	gray matter rate measured with MRI scan	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis pain	Measured by visual analogue scale (0 to 10)	at baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2016
• Primary Completion (Actual): February 11, 2019
• Study Completion (Actual): February 11, 2019

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Neuralgia; Atrophy
• Other Study ID Numbers: 1308174; 2013-A01791-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No